MAUDE Adverse Event Report: BOSTON SCIENTIFIC; CATHETER

Device Problem Human-Device Interface Problem (2949)

Patient Problem Cardiac Perforation (2513)

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that during placement of lead, this catheter could have possibly caused a perforation in the heart wall.The product was never in service.No additional adverse patient effects were reported.

• Type of Device: CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC
• Manufacturer Contact: timothy degroot ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515826168
• MDR Report Key: 6973111
• MDR Text Key: 90077099
• Report Number: 2124215-2017-19740
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (B)(4); (B)(4)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 93 YR